Effects of Celecoxib After Percutaneous Coronary Intervention
Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial
1 other identifier
interventional
260
1 country
1
Brief Summary
Several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 15, 2006
CompletedFirst Posted
Study publicly available on registry
February 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJuly 21, 2011
July 1, 2011
4.2 years
February 15, 2006
July 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Late luminal loss at 6 months
6 months
Study Arms (2)
Control
NO INTERVENTIONCelecoxib
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography
You may not qualify if:
- Acute ST elevation MI
- Left main disease
- Contraindications to aspirin, clopidogrel or celecoxib
- Severe congestive heart failure
- Expected survival \< 2 years
- Hepatic dysfunction
- Currently taking NSAIDs or any COX-2 inhibitor
- Renal dysfunction
- Use of warfarin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (2)
Chung JW, Yang HM, Park KW, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Koo BK, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Long-term outcome of adjunctive celecoxib treatment after paclitaxel-eluting stent implantation for the complex coronary lesions: two-year clinical follow-up of COREA-TAXUS trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):243-8. doi: 10.1161/CIRCINTERVENTIONS.109.889881. Epub 2010 May 18.
PMID: 20484099DERIVEDKoo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74. doi: 10.1016/S0140-6736(07)61295-1.
PMID: 17707751DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bon-Kwon Koo, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 15, 2006
First Posted
February 16, 2006
Study Start
August 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
July 21, 2011
Record last verified: 2011-07